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U.S. regulators broadened the authorized use of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to age 65.

Before the announcement, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in premenopausal females.

The drug was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi applauded the FDA’s action to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other specialists in female health expressed support for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the available data.

While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the placebo, but the degree of the improvement is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was originally developed as an antidepressant but was found to be lacking during initial trials.

However, researchers observed improvements in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for serious side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

The label advises allowing a two-hour gap after drinking before using the drug to minimize the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the interaction. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“These studies aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for older females.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at age 65.

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a different group of women who may benefit.

“I believe it will benefit this population better as long as they have no other health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, treating these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also occasionally used without formal approval to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing libido include:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”